On June 16, 2016, FDA-CDRH published a draft guidance document entitled Factors to Consider Regarding Benefit-Risk in Medical Device Product Availability, Compliance, and Enforcement Decisions. The draft guidance is available from FDA as UCM506679. In addition, FDA opened a docket, FDA-2016-D-1495, on www.regulations.gov.
The draft guidance provides a framework by which FDA would make decisions on compliance and enforcement then there might be issues of patient safety or device availability. The draft guidance builds on factors in the premarket review benefit-risk framework to help provide consistency across the total product life cycle.
The draft guidance describes the factors to assess benefits and risks as well as other factors to consider. It includes worked examples and provides worksheets to help perform the assessments.